cGMP and Regulatory Updates

1.0 PURPOSE: To provide a written procedure for usage and maintenance of wet and dry bulb Hygrometer & to provide a schedule and acceptance criteria for Temperature & Relative humidity (RH) recorded in controlled areas. 2.0 SCOPE: Applicable to all wet and dry bulb hygrometers used for checking temperature and relative humidity in controlled areas within Factory premises. 3.0 RESPONSIBILITY: Concerned Departmental Executives and Departmental Heads. 4.0 ACCOUNTABILITY: Plant Manager and Manager Quality Assurance 5.0 DEFINITIONS: Nil. 6.0 PROCEDURE: 6.1 PREPARATION OF THE INSTRUMENT: 6.1.1 Check and ensure that the wick is fixed on the wet bulb hygrometer. 6.1.2 Fill the cistern with potable water at the start of the shift. 6.1.3 Check and ensure that the wick is wet. 6.1.4 Check the mercury columns of the thermometer for any break in the column before taking to the area to be monitored 6.2 OPERATION: 6.2.1 Remove the hygrometer from the pouch and rotate gently for 50 to 60 times...

1.0 PURPOSE : To provide a written procedure for cleaning of Toilets. 2.0 SCOPE : Applicable to cleaning of Toilets ( Gents and Ladies) 3.0 RESPONSIBILITY: Housekeeping staff. 4.0 ACCOUNTABILITY: Housekeeping supervisor 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 CLEANING AIDS: 6.1.1 Cleaning using dry & wet cleaning mop. 6.1.2 Phenoyl It is used for scrubbing the floor. 6.1.3 Harpic for cleaning of Hand wash Sinks, Urinal functional, lavatory, 6.1.4 Pipe brush. 6.1.5 Cobweb brush. 6.1.6 Duster Cloth. 6.2 Cleaning of Floor and Wall 6.2.1 Pour plenty of water on the floor and drain the water, then do the wet mop, then mop with phenoyl, 6.2.2 Clean the wall with wet cloth; clean the electrical board with dry cloth. 6.3 Cleaning of Hand Wash Sink, Urinal functional, lavatory 6.3.1 Spread the water all around the sink, Urinal functional, lavatory then apply Harpic all around the sink wait for 5 minutes then scrub with brush and pour sufficient quantity of water to remove the cleaning agent...

1.0 PURPOSE: To provide a written procedure for Pest and Rodent control. 2.0 SCOPE: This procedure is applicable to Control of Pest and Rodents in the plant. 3.0 RESPONSIBILITES: Authorized person appointed for Pest Control Agency House Keeping supervisor 4.0 ACCOUNTABILITY: Executive Human Resources 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 HOUSE PEST MANAGEMENT: Frequency: Fortnightly 6.1.1 This treatment is for the management of cockroaches and other pests such as silver fish, red and black ants. 6.1.2 This treatment mainly comprise of a through insecticidal spray in all the nooks and corners of the entire premises and other vulnerable places harbouring cockroaches and other insects. 6.1.3 The treatment is based on the use of gel bait i.e Goliath Gel and water based Deltamethrin , Cyfluthrin done by authorized PCA person only. 6.1.4 Enter the log after the House Pest Management treatment in Format Prescribed for the same 6.2 RODENT CONTROL: 6.2.1 This treatment is f...

1.0 PURPOSE: To provide a written procedure to render immediate First Aid during normal or emergency situations 2.0 SCOPE: This procedure is applicable to render first aid during emergency situations. 3.0 RESPONSIBILITY : Executive Human Resources 4.0 ACCOUNTABILITY: Plant Manager 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 REST ROOM : 6.1.1 The first aid box is equipped with all the necessary items required for First Aid. 6.1.2 Any injured person shall be immediately shifted to the rest room for First Aid. 6.2 FOR CUTS AND WOUNDS: 6.2.1 Try to stop bleeding at first instance by application of ice. Do not press the bleeding part very strongly. 6.2.2 Cover the wound with clean cloth / sterile gauze, and apply gentle pressure. 6.2.3 If a body part is severely wounded, send the victim to the hospital along with an escort. 6.3 FOR BURNS: Note : Never use iodine, cotton, oil or greasy ointment. 6.3.1 For surface burns of minor nature, submerge the part in ice cold water...

1.0 PURPOSE : This procedure describes the details of cleaning aids and detailed procedure for the cleaning of Primary and Secondary Footwear. 2.0 SCOPE : Applicable to cleaning of footwear in the production block. 3.0 RESPONSIBILITY: Housekeeping staff. 4.0 ACCOUNTABILITY: Housekeeping Supervisor. 5.0 DEFINITIONS: Nil. 6.0 PROCEDURE: 6.1 CLEANING AIDS: 6.1.1 Soap solution. 6.1.2 Dettol 6.1.3 Brush. 6.1.4 Lint free duster. 6.2 PRIMARY FOOT WEAR: 6.2.1 Collect all the footwear from the primary footwear lockers in a polythene bag at end of the shift on weekend and take it to the wash area. 6.2.2 Prepare the soap solution by adding 500 ml of liquid soap in 20 liters of water. 6.2.3 Soak the footwear for 10 minutes in soap water solution. 6.2.4 Scrub the footwear surface from outside and inside with brush. 6.2.5 Flush the footwear with clean Potable water. 6.2.6 Prepare disinfectant solution (Dettol) by adding 250 ml of Dettol in 10 liters of water. 6.2.7 Dip the washed footwear in disinfe...

1.0 PURPOSE: To provide a written procedure for cleaning of waste bins. 2.0 SCOPE: Applicable to the waste bins used in all departments. 3.0 RESPONSIBILITY: Housekeeping staff. 4.0 ACCOUNTABILITY: House keeping supervisor 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 Remove the polythene bag and the contents inside, sent for disposal. 6.2 Take the waste bin to washing area. 6.3 Clean the lid, internal and external part each with about 10 kg of Potable water followed by cleaning with 0.1% Sodium Lauryl Sulphate solution. 6.4 Wash the lid, internal and the external part each with about 10 kg of Potable water to remove the traces of the cleaning agent. 6.5 Finally rinse the lid, internal and the external parts of the waste bin with about 10 kg of Purified water. 6.6 Wipe out the bin with dry lint free cloth. Use compressed air, if necessary. 6.7 Place a clean polythene bag inside the waste bin and transfer to the area of the use. 6.8 Enter the cleaning details in the Cleaning record of waste bi...

1.0 PURPOSE : To provide a written procedure for cleaning of general areas. 2.0 SCOPE : Applicable to cleaning of reception, conference, dining area. 3.0 RESPONSIBILITY: Housekeeping helper. 4.0 ACCOUNTABILITY : Supervisor Housekeeping 5.0 DEFINITIONS: Nil. 6.0 PROCEDURE: 6.1 CLEANING AIDS: 6.1.1 Two –in –one Vacuum Cleaner : It is used for dry & wet cleaning 6.1.2 Backpack Vacuum Cleaner : It is used for de-dusting. 6.1.3 Glass cleaning apparatus: It is used for cleaning the glasses 6.1.4 Cleaning equipment Trolley 6.1.5 Pipe brush 6.1.6 Duster Cloth 6.1.7 Savlon 6.1.8 Dettol 6.1.9 Room Freshener 6.2 GENERAL AREAS: 6.2.1 Start the cleaning activity from outside staircase with dry cleaning followed by wet cleaning system. Clean the door mats. 6.2.2 Dry clean the reception area, doors, glass panel, furniture, wastebin, water cooler and electrical fittings with duster followed by wet cleaning except electrical fittings. Use vacuum cleaner to clean hard-to-clean area and ceiling. 6.2...

1.0 PURPOSE : To provide written procedure for cleaning of change rooms. 2.0 SCOPE : Applicable to cleaning of change rooms in the production block. 3.0 RESPONSIBILITY: Housekeeping staff. 4.0 ACCOUNTABILITY: Housekeeping supervisor 5.0 DEFINITIONS: Nil 6.0 PROCEDURE 6.1 CLEANING AIDS: 6.1.1 Pipe brush. 6.1.2 Cobweb brush. 6.1.3 Duster Cloth. 6.1.4 Savlon 6.1.5 Dettol 6.2 PRIMARY CHANGE ROOM: 6.2.1 Clean the doors, waste bins, lockers, crossover benches, shoe covers dispenser, soap dispenser, visitors uniforms cupboard, used uniforms bin etc with duster cloth, Savlon / Dettol. 6.2.2 Clean change room electrical fittings with dry duster cloth. 6.2.3 Clean the change room floor with dry mopping followed by wet mopping with Savlon / Dettol. 6.2.4 CLEANING FREQUENCY : For point nos 6.2.1 & 6.2.2: Twice in a day i.e. at the start of the shift and end of the shift. For point no 6.2.3: Thrice in a day (during working hours) i.e. at the start of the shift , after lunch hour and end of the ...

1.0 PURPOSE: To provide a detailed procedure for the visitors entry / exit through secondary change room. 2.0 SCOPE: Applicable to all visitors entering and leaving production area located on first floor. 3.0 RESPONSIBILITY: Personnel department and Management staff 4.0 ACCOUNTABILITY: Plant Head 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 ENTRY PROCEDURE: 6.1.1 Proceed from primary corridor to enter the secondary change room. 6.1.2 The responsible person accompanying the visitor will swipe the access card to enter the secondary change room. 6.1.3 Wear the second shoe cover over the first shoe cover while crossing over the crossover bench. 6.1.4 Collect secondary over gown and disposable nose mask Wear the secondary over gown. 6.1.5 Disinfect your hands with the disinfectant. 6.1.6 Push the door and enter secondary corridor. 6.2 EXIT PROCEDURE: 6.2.1 Pull the door and enter secondary change room. 6.2.2 Remove the secondary over gown and drop it in the waste bin. 6.2.3 Remove the nose mask ...

1.0 PURPOSE: To provide a detailed procedure for the visitors entry / exit through primary change room. 2.0 SCOPE: Applicable to the visitors entering and leaving production area. 3.0 RESPONSIBILITY: All Employees and Management Staff. 4.0 ACCOUNTABILITY: Plant Manager 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 ENTRY PROCEDURE: 6.1.1 Enter into the building through the reception main door. Report the belongings like watches, ornaments, mobile phones, handbag and briefcase etc. 6.1.2 If required use the toilet, washbasins and hand drier located before entering the change room. 6.1.3 Push the door to enter the change room. 6.1.4 Collect the clean primary uniform (Cap, overcoat) from the cabinet. 6.1.5 Wear the clean primary uniform. 6.1.6 Wear the disposable shoe cover on the street footwear while crossing the cross over bench. 6.1.7 Ensure for complete covering of hair including ears and uniform is properly fastened. 6.1.8 Disinfect your hands using disinfectant. 6.1.9 Pull the door to e...

1.0 PURPOSE: To provide a written procedure for the entry / exit through secondary change room. 2.0 SCOPE: Applicable to all personnel (gents and ladies) entering and leaving production area. 3.0 RESPONSIBILITY: All Employees. 4.0 ACCOUNTABILITY: Plant Manager 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 ENTRY PROCEDURE: 6.1.1 Proceed from primary corridor, swipe the access card and enter the secondary change room 6.1.2 Remove primary footwear and store in the primary footwear storage compartment in the cross over bench. 6.1.3 Cross the cross over bench. 6.1.4 Collect secondary wear from the secondary uniform lockers. Gents : Boiler suit and snood Ladies : Over gown and snood Department : Colour code Production : Light green Quality assurance : Cream Quality control : White Stores : Sky blue Maintenance : Navy blue House keeping : Light blue 6.1.5 Wear snood over the primary cap and tie the knot. 6.1.6 Wear the boiler suit / over gown inserting the hanging flaps of snoo...

1.0 PURPOSE : To provide a written procedure for the medical check up. 2.0 SCOPE : Applicable to all employees joining the company. 3.0 RESPONSIBILITY: Registered Medical Officer , Human Resource Executive 4.0 ACCOUNTABILITY: Human Resource Manager 5.0 DEFINITIONS: Nil. 6.0 PROCEDURE : 6.1 Company should make a contract with Registered Medical Officer for checking physical fitness of the employees. 6.2 Every new recruit should under go medical examination before joining the company. 6.3 Medical examination should be carried out once in a year for all the employees. 6.4 Medical examination should include the tests like Hb, TC, DC, ESR, Chest PA X-ray, ECG, Urine RE,RBS and urea- Package I Penicillin Allergic test Package II 6.5 Employee should not report to the work if they are infected with any disease or they have any open lesions. 6.6 About illness during working hours employee should report to his/her dep...

1.0 PURPOSE: To provide a written procedure for the entry / exit through primary change room. 2.0 SCOPE: Applicable to all personnel (Gents and Ladies) entering and leaving production area . 3.0 RESPONSIBILITY: All employees. 4.0 ACCOUNTABILITY: Plant Manager. 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 ENTRY PROCEDURE: 6.1.1 Remove the street footwear and keep them in the street footwear racks/ Cupboards. 6.1.2 If required use the toilet and washbasins located beside the main door before removing the street foot wear. 6.1.3 Push the door and enter the first change room. 6.1.4 Keep the personnel belongings in the lockers provided. 6.1.5 Remove street clothes and keep them in the street clothes lockers provided. 6.1.6 Wash your hands in the wash tap provided. 6.1.7 Dry your hands using hand drier. 6.1.8 Cross the crossover bench and enter the second change room. 6.1.9 Collect the clean primary uniform from the locker provided and wear. Gents: Pant, Shirt and cap. Ladies: Churidhar and ca...

1.0 PURPOSE: To provide a standard procedure for Recruitment Policy. 2.0 SCOPE: This procedure is applicable for the recruitment, selection and placement of an employee in XXXXX company 3.0 RESPONSIBILITY: HR Manager (Corporate office) HR Executive 4.0 ACCOUNTABILITY: Plant Manager GM Quality Assurance 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 In order to have right person for the right job, selection procedures have been defined. 6.2 For Pharmaceutical Industry the following departments have been identified. a) Human Resources b) Stores c) Manufacturing d) Packaging e) Quality Control f) Quality Assurance g) Regulatory Affairs i) Maintenance j) House Keeping 6.3 In order to elaborate and explain the responsibilities of each department head and their subordinates and to cover all functions and authorities the following is the organization chart adopted with required Qualification, Experience and number of positions in each departme...

SOP: Cleaning Procedure for Raw Material Stores Dispensing Equipments Procedure For every drug substance its dedicated equipments is used. On each piece of equipment name of the drug substance for which it is reserved has been engraved. Dispensing equipment's used for excepients is not dedicated. However, cleaning procedure for all the equipments is same. After completing the dispensing operation, the dispensing equipment is carefully wrapped in a polythene bag and placed in a plastic box, which has been labeled as “USED SCOOPS, SPATULAS FOR CLEANING”. The Equipment is scrubbed with 2.0% TEEPOL solution and rinsed under running tap. To remove sticky substances, the equipments are rinsed with hot water and scrubbed with 2.0% TEEPOL solution after rinsing under running tap water. The equipment is rinsed with distilled water and allowed to drain. Then the equipment is sprayed with 70% IPA and dried with hand held drier. The cleaned and dried equipment ...

SOP: Cleaning Procedure for Open Space Procedure 1. Walls and Windows : Wipe the entire halls and glass windows with soap solution followed by dry lint free cloth. 2. Floor : Morning : Clean the entire floor using soap water, subsequently spray the floor with diluted phenyl and wipe it once again. 3. Evening: Clean the entire floor using soap water, subsequently spray the floor with diluted phenyl and wipe it once again. SOP : Cleaning Schedule for General Space 1. WALLS AND WINDOWS: Wipe the entire walls and glass windows with clean towel every day. 2. FLOORS: 1. First cleaning in the morning: Clean the entire floor using soap water, subsequently spray the floor with diluted phenyl and wipe it once again. 2. Subsequent cleaning: Clean the entire floor using Soap water, once in every two hours. {Note: Follow the same procedure with different cleaning agents like Det...

Precautions for Preparing SOP’s Instructions and Procedures should be written in a clear language, specifically applicable to the facilities provided. Records are make in such a way that during manufacturing process, it will show that all the steps required by the defined procedures and instructions have in –fact been taken and that the quantity and quality of the product is as expected. Any significant expected deviation are fully recorded and investigated. Procedures Documents required are to be designed, prepared, received and distributed with such a care that it will comply with the relevant parts of the manufacturing and operating procedures as well as facilities available. Documents will be approved, signed and dated by appropriate authorised persons and person nominated by the management. Persons Having Authority may include i. Nominee of local staff, expert in his own field and familiar with Good Manufacturing Practices ii. E.D (Opera...

1.0 Objective To lay down a procedure for operation and calibration of CP225D analytical balance to give accurate and reproducible results. 2.0 SCOPE This sop covers the operation and calibration procedure of analytical Balance and it is applicable to Quality control department. 3.0 Responsibility Officer / Executive 4.0 Accountability Department Head 5.0 Procedure 5.1 general cleaning PROCEDURE 5.1.1 Ensure that the power supply to the balance is switched ‘ OFF’ before cleaning 5.1.2 Clean the pan and inside of the balance with a brush. 5.1.3 Clean the outside of the balance with a clean dry cloth every day. occasionally wet cloth dipped in dilute soap solution maybe used .Precaution has to be taken to clean the balance immediately with dry cloth to remove the moisture. 5.2 Operating Instructions 5.2.1 Ensure that the balance is properly connected to power supply. 5.2.2 Check that the spirit level is in the center of the level or not and if necessary adjust the level by turning the le...

1.0 OBJECTIVE To ensure that the instrument performs satisfactorily and gives accurate and reproducible results. 2.0 SCOPE This SOP covers operation and calibration procedure for Infra red spectrophotometer and this SOP is applicable to Quality control department. 3.0 RESPONSIBILITY Officer / Executive. 4.0 ACCOUNTABILITY Department Head 5.0 PROCEDURE 5.1 PROCEDURE FOR GENERAL CLEANING 5.1.1 Ensure that the power supply to the instrument is switched OFF before cleaning. 5.1.2 De-dust the instrument with a clean dry cloth every day. 5.1.3 Once in a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to remove traces of detergent. 5.1.4 Caution to be taken to clean the oven immediately with dry cloth to remove the moisture. 5.2 PROCEDURE FOR OPERATION 5.2.1 Switch on the ...

1.0 OBJECTIVE To ensure that Magnetic Stirrer with hot plate performs satisfactorily. 2.0 SCOPE This sop covers the operation procedure for Magnetic stirrer with hot plate and this is applicable to Quality control department.. 3.0 RESPONSIBILITY Quality Control officer/ Executive. 4.0 ACCOUNTABILITY Department Head. 5.0 PROCEDURE 5.1 PROCEDURE FOR CLEANING 5.1.1 Ensure that the power supply to the instrument is switched OFF before cleaning. 5.1.2 De dust the instrument with a clean dry cloth every day. 5.1.3 Once in a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to remove traces of detergent...